SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX®-Trial).
- Registration Number
- NCT02002247
- Lead Sponsor
- Daren K. Heyland
- Brief Summary
The aim of the investigators' research program is to investigate the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery. The investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a fewer complications, less organ injury and fewer deaths. Before the investigators conducted the large definitive trial, they conducted a pilot study to assess the feasibility of the protocol, and are rolling the pilot patients into the definitive trial.
- Detailed Description
Over a million patients undergo open heart surgery annually and this number is likely to accelerate as the population ages and the prevalence of diabetes and cardiovascular disease continue to increase. Unfortunately, death, organ failure, and other serious complications are all too frequent following open heart surgery, especially in some high-risk patient populations.
Selenium is a trace element that is important for many of the body's regulatory and metabolic functions especially during times of stress. International members of the study team have shown in a non-randomized study that high dose selenium supplementation was associated with improved clinical outcomes compared to a historical control group. The next step in this program of research is to conduct a randomized trial.
The aim of this research program is to investigate the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery. The investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to fewer complications, less organ injury and fewer deaths.
The investigators propose to conduct a randomized, placebo-controlled, double-blind, multicentre definitive trial of 1400 patients across 20 sites in Germany and Canada, which will include the pilot study patients. An industry partner (Biosyn) will provide the product and some additional support for the European sites. Patients will be randomized to receive either a daily perioperative high-dose selenium or placebo until postoperative day 10 (maximum) or upon earlier discharge from ICU. If the hypothesis is proven true, and this simple, inexpensive nutrient reduces complications and improves recovery of patients undergoing cardiac surgery, there is the potential to dramatically change clinical practice and improve health outcomes.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1400
-
Adult patients (>/=18 years of age)
-
Scheduled to undergo elective or urgent cardiac surgery with the use of cardiopulmonary bypass (CPB) and cardioplegic arrest that exhibit a high perioperative risk profile as defined by the presence of one or more of the following:
- a) Planned valve surgery combined with CABG or multiple valve replacement/repair surgeries or combined cardiac surgical procedures involving the thoracic aorta; OR
- b) Any cardiac surgery with a high perioperative risk profile, defined as a predicted operative mortality of ≥ 5% (EuroSCORE II).
We will exclude patients who meet any of the following criteria:
- Isolated procedures (CABG only or valve)
- Known hypersensitivity to sodium-selenite or to any of the constituents of the solution.
- Renal failure requiring dialysis at the point of screening.
- Chronic liver disease as evidenced by a pre-operative total bilirubin >2 mg/dl or 34 umol/L.
- Disabling neuropsychiatric disorders (severe dementia, severe Alzheimer's disease, advanced Parkinson's disease).
- Pregnancy or lactation period.
- Simultaneous participation in another clinical trial of an experimental therapy (co-enrolment acceptable in observational studies or randomized trials of existing therapies if permitted by both steering committees and local ethics boards).
- Patients undergoing heart transplantation or preoperative planned LVAD insertion or complex congenital heart surgery.
- Alternate contacts of investigators (required by German Regulatory Authorities).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Normal saline will be administered to subjects intravenously pre-operatively, upon admission to the ICU, then daily up to post-operative day 10 or ICU discharge, whichever occurs first. sodium selenite sodium selenite High-dose sodium-selenite will be administered to subjects intravenously: 1) pre-operatively (2000 ug); 2) upon admission to the ICU (2000 ug), 3) then daily (1000 ug) up to post-operative day 10 or ICU discharge, whichever occurs first.
- Primary Outcome Measures
Name Time Method PODS free days + alive 30 Day Evaluate the PODS free days + alive as the primary outcome for the large-scale Phase III trial. We define PODS as the need for life-sustaining therapies (mechanical ventilation, vasopressor therapy, mechanical circulatory support, continuous renal replacement therapy, or intermittent hemodialysis).
- Secondary Outcome Measures
Name Time Method Hospital Re-admission Rates 6-months To be assessed up to 6-months post-randomization.
30-Day Mortality 30 Day Mortality 30 days post-randomization.
Hospital Acquired Infections 30 day To be evaluated up to 6 months post-randomization.
Duration of Mechanical Ventilation 6-months To be assessed up to 6-months.
Quality of Life 6-months Health related quality of life to be assessed up to 6-months post-randomization.
Perioperative hemodynamic profile 6 months This includes: mean arterial blood pressure, cardiac power index, systemic vascular resistance, etc... To be assessed up to 6-months post-randomization.
Cardiovascular Complications 6-months This includes: arrhythmias, cardiac arrest, infarction. To be assessed up to 6-months.
ICU Length of stay 6-months To be assessed up to 6 months post-randomization.
6-Month Survival 6-months To be assessed at 6 months post-randomization.
Return to work 6-months Assessed using a questionnaire to determine the patient's ability to return to their pre-operative working capabilities. To be assessed up to 6 months post-randomization.
6-minute walking test up to 3 months 6-minute walking distance
Incidence of post-operative delirium 6-months Assessed by CAM-ICU score. To be assessed up to 6-months.
Hospital Length of stay 6-months To be assessed up to 6 months post-randomization.
Trial Locations
- Locations (23)
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Sir Mortimer B. Davis Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Sacre Coeur
🇨🇦Montreal, Quebec, Canada
IUCPQ
🇨🇦Quebec City, Quebec, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Centre de recherche CIUSSS de l'Estrie CHUS
🇨🇦Sherbrooke, Quebec, Canada
Klinik für Her- und Gefäßchirurgie Universitäts-Herzzentrum Freiburg
🇩🇪Freiburg, Germany
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Institut de cardiologie de Montreal
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
RWTH Aachen University Hospital
🇩🇪Aachen, Germany
Klinik und Poliklinik für Herz- und Thoraxchirurgie Uniklinik Köln
🇩🇪Koln, Germany
Klinik für Herz-, Kinderherz- und Gefäßchirurgie UKGM Giessen
🇩🇪Gießen, Germany
University Medical Center Schleswig-Holstein
🇩🇪Kiel, Germany
Klinik für Anästhesiologie Universitätsmedizin Mainz
🇩🇪Mainz, Germany
Klinik für Anästhesiologie Klinikum der Universität München
🇩🇪München, Germany
Klinikum Oldenburg gGmbH Universitätsklinik für Anästhesiologie / Intensivmedizin / Notfallmedizin / Schmerztherapie
🇩🇪Oldenburg, Germany
Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie Universitätsmedizin Münster, Zentralklinikum
🇩🇪Münster, Germany
Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin Universitätsklinikum Bonn
🇩🇪Bonn, Germany
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada